Health eBrain Study

The Health eBrain Study is a research study led by Dr. Corinna Lathan (AnthroTronix) and Steve Sidel (Mindoula).

Dr. Lathan and the Health eBrain Study staff are available to answer any questions you may have.

Research studies include only people who choose to participate. Please take your time making your decision to participate. If you have any questions, you may ask the researchers.

Why is this study being done?
The primary purpose of this study is to track caregiver health via survey responses and cognitive data over 12 weeks, both with and without an intervention, and to obtain feedback from the caregivers themselves to design future interventions.

How many people will take part in this study?
We hope to enroll up to 400 participants for the overall study, with the 400 participants being assigned to one of the three sections of the study (Mindoula + DANA, Waitlist or DANA).

Am I eligible to participate in the study?
To participate, in the Mindoula + DANA or waitlist arms of the study you need to be:

Between the ages of 45-75 years old

Be Male or Female

Have not been diagnosed with a cognitive impairment (for example: Mild Cognitive Impairment or Dementia)

Cannot be color-blind

You must be an informal, unpaid caregiver of someone who has been diagnosed with Alzheimer’s

You must be currently be providing care and have been caregiving for at least one year

You must be providing care for more than 20 hours per week* (Not required for DANA section)

You must have access to the Internet both through desktop computer and an Android or iOS smartphone

You will only be assigned to the Mindoula section of the study if you score as having significant risk for a mental health disorder or medium to high risk of depression and have a high level of caregiver burden as evaluated during the screening process using the surveys outlined below. All others will be assigned to an appropriate section.

What will happen if I take part in this research study?Surveys
If you agree to participate in the Health eBrain Study, you will be asked to complete a demographics survey that will ask about such things as your age, gender, education, and caregiver role. The demographics survey will take less than 10 minutes to complete for most people.

You will also be asked to complete three health surveys: the Zarit Burden Interview to assess caregiver burden, which contains 22 questions and the PROMIS Sleep Disturbance survey, with 8 questions, which assesses your sleep. Finally, you will be asked to take the M3, which is a brief, self-reported screen that assesses Depression, Anxiety, Bipolar Disorder, and PTSD. The M3 has 27 questions. The three surveys combined should take less than 20 minutes to complete for most people. When you are assigned to your section, you will be asked to take the PAL, a test of visual memory and new learning, and the PERMA, an assessment of your current emotional, physical, and mental well-being. These two tests should take approximately 15 – 20 minutes to complete.

Mindoula + DANA
If selected to participate in the study and to receive the intervention, you will be instructed to download both the Mindoula and DANA apps and will then be assigned a case manager. Your M3 data will be reviewed by the consulting psychiatrist. You will then, over the course of 12 weeks, work with your case manager on agreed upon goals and use the Mindoula application to communicate with your case manager. Interventions from the case manager can include referral to needed resources (e.g., respite care), behavioral activation, an evidence-based intervention for depression, and SMART goal setting to address needed tasks, among others.

In addition to Mindoula, you will be regularly prompted to answer brief questions about your mood, functioning, and sleep to further tailor the intervention. Once a week, you will be prompted to use the DANA application. If you would like to take DANA more than once per week, you can use it as often as you would like. DANA will include a cognitive battery of three tests and wellness survey of four Ecological Momentary Assessments, that take no longer than 5 minutes.

Waitlist Controls
Due to limited availability, not all eligible participants will be selected to receive the above intervention. Within a few weeks of your registration, you will be informed whether or not you are on the waitlist. If you are on the waitlist, you will take the surveys at weeks 4, 8, and 12. At then end of those 12 weeks, you will then be enrolled into the DANA Wellness group and receive DANA for 12 weeks.

DANA Wellness
All other participants who do not qualify for the intervention or waitlist arms of the study will be eligible to receive the DANA application. DANA will be taken at the beginning of the study, then at weeks 4, 8, and 12. You will also take a usability survey with questions on your experience with DANA at those same time intervals (weeks 4, 8, and 12).

Wellness surveys consisting of four Ecological Momentary Assessments will also be provided during the course of your participation.

How long will I be in the study?
Participation in this study will last 12 weeks after downloading the Mindoula and DANA apps. Inclusion in the study may be up to a few weeks longer depending on how much time passes between screening and initial sign-up and receiving the Mindoula and DANA apps.

Can I stop being in the study?
Yes. You can decide to stop at any time. We won’t delete the information about you that we’ve already collected, but we will stop collecting any new information about you and will stop contacting you.

What side effects or risks can I expect from being in the study?
Although we will do our best to protect your study information (see below), there is still a very small risk of loss of privacy. Please see our privacy policy on the website.

Some participants will not selected to be a part of the Mindoula intervention, but will have a score that indicates Depression, Anxiety, PTSD, Bipolar Disorder, and/or sleep disturbance, Mindoula staff will take the following steps to ensure that no harm comes to these participants by doing the following:

Encouraging participants with these scores to take a printed copy of their results to their therapist, psychiatrist, primary care physician or other appropriate treatment team member for follow up and possible treatment.

Crisis support information specific to Depression, Anxiety, PTSD, and Bipolar Disorder,will be provided to all users regardless of score.

For more information about risks and side effects, ask one of the researchers.

Are there benefits to taking part in the study?
For those selected for it, the intervention provided in this study may benefit your overall mental health. It will provide tools and resources that can help you manage your mental health and the stresses of caregiving, as well as access to a trained case manager and psychiatrist, all of which you might not have otherwise had access. In addition, both you and your Mindoula case manager and psychiatrist will have access to your cognitive data through the DANA app, which will provide another layer of information not typically available to mental health practitioners, meaning they can better tailor your intervention to your needs, and you can easily track your own progress.

What other choices do I have if I do not take part in this study?
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you.

We will do our best to make sure that the personal information in your record is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings or shared with other researchers interested in brain health your name and other personal information will not be used.

How is my information protected?
We will do our best to make sure that the personal information we collect about you is kept private and secure. The Health eBrain Study will never sell, rent, or lease your contact information. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. However, we cannot guarantee total privacy — your personal information may be given out if required by law (e.g., to prevent possible injury to yourself or others).

Your information will be transmitted and stored using very secure systems. The network servers where your data are stored sit behind firewalls that do not allow unauthorized access and are physically located in a secure server room that can only be accessed by critical staff members. If you interact with Mindoula, you will interact through their secure app that has privacy protection. Interactions with a caseworker will remain confidential and not be shared with anyone.

What are the costs of taking part in this study?
You will not be charged for any of the study treatments or procedures.

Will I be paid for taking part in this study?
You will not be paid for taking part in this study.

What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you.

We will tell you about new information or changes in the study that may affect your willingness to continue in the study.

Who can answer my questions about the study?
You can talk with the study researcher or study staff about any questions, concerns, or complaints you have about this study by calling 301-495-0770 and leaving a message or by emailing your study at studycoordinator@health-ebrainstudy.org, , or by using one of the other options described in the “Contact Us” section of the website.

If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, contact the IRB Administrator, Charlotte Safos, via email at csafos@atinc.com

CONSENT

You can access and print copies of this consent form whenever you like via the study website.

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty.

If you wish to be in this study, please select the following statement and click submit.

I confirm that I have read and understood this consent form and that, by clicking “Submit” below, I am voluntarily giving my consent to participate in this study. I understand that my 12-week participation can include taking on-line surveys, on-device applications, and providing personal information. I understand all my data will be kept as secure as possible. I also understand that I can, by contacting studycoordinator@health-ebrainstudy.org, exercise my right to withdraw at any time or have any questions answered.

Clinical Trials Registration
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.